Mightier Play and Caregiver Stress and Wellbeing
The primary goal of this study is to demonstrate that digital mental health interventions for children, such as Mightier, can have an impact on caregiver functioning, including parenting stress, overall wellbeing, and work engagement. Participants will be caregivers of children who are using Mightier, a video-game based heart rate biofeedback intervention used to build emotion regulation. Caregivers will be asked to complete a short survey prior to their child's first play and then complete that survey two more times, at 8 weeks and 12 weeks post baseline. The pre-post self report design will allow us to observe changes during Mightier use and relate those changes to overall engagement with the intervention.
Conditions:
🦠 Stress
🗓️ Study Start (Actual) 9 January 2023
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 30 June 2025
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Parent or caregivers have a child engaging with the heart rate biofeedback intervention Mightier
    • * Parent or caregivers reside in the United States

    Exclusion Criteria:

    • * None
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 December 2022
  • First Submitted that Met QC Criteria 7 December 2022
  • First Posted 15 December 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 March 2023
  • Last Update Posted 23 March 2023
  • Last Verified March 2023